29 hours ago House report on PATIENT SAFETY AND QUALITY IMPROVEMENT ACT. This report is by the Energy and Commerce ... H. Rept. 108-28 - PATIENT SAFETY AND QUALITY IMPROVEMENT ACT 108th Congress (2003-2004) Committee Report Hide Overview . Report Type: House Report: … >> Go To The Portal
To implement the Patient Safety Act, the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) published the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule). AHRQ has received many questions regarding the implementation of the Patient Safety Rule and about PSOs.
Joint Patient Safety Reporting All Military Health System Direct Care Direct care refers to military hospitals and clinics, also known as “military treatment facilities” and “MTFs.” direct care facilities must report qualifying patient safety events to the DoD Patient Safety Program through Joint Patient Safety Reporting
The Patient Safety Act authorizes AHRQ to list or designate entities as Patient Safety Organizations (PSOs) that attest to having expertise in identifying the causes of, and interventions to reduce the risk of, threats to the quality and safety of patient care.
The Patient Safety Rule requires an entity to certify that it meets 15 distinct statutory requirements; a component of another organization must attest that it meets another three statutory requirements; and each entity or component organization must comply with several additional regulatory requirements.
Final Report to Congress To Improve Patient Safety Outlines Strategies To Speed Progress. A final report (PDF, 1.16 MB) on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ.
OCR enforces these confidentiality protections. AHRQ lists patient safety organizations pursuant to section 924 of PSQIA and has responsibility for common formats and network of patient safety databases pursuant to section 923. Learn more about the Patient Safety Rule and read the regulations.
California Department of Public Health. The Center is responsible for regulatory oversight of health facilities, health professionals, and clinical and public health laboratories to secure safe, effective, and quality health care for all Californians.
The Joint Commission's standards address safety culture in Standard LD. 03.01. 01, which requires leaders to create and maintain a culture of safety and quality throughout the critical access hospital. By reporting and learning from patient safety events, staff create a learning organization.
Patient Safety Organizations (PSOs) conduct activities to improve the safety and quality of patient care.
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Office for Civil Rights (OCR), Department of Health and Human Services (HHS).
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
The OSHA website has information about OSHA standards and health and safety topics by subject and industry, including a page devoted to healthcare facilities.
What reports are encourage as a result of the patient safety and quality improvement act? near misses, unsafe conditions, adverse events, events the threaten patient safety.
The Joint Commission accredits and certifies more than 22,000 health care organizations and programs in the United States, including hospitals and health care organizations that provide ambulatory and office-based surgery, behavioral health, home health care, laboratory and nursing care center services.
In 2002, The Joint Commission established its National Patient Safety Goals (NPSGs) program; the first set of NPSGs was effective January 1, 2003.
The Joint Commission (TJC) is an independent, not-for-profit organization created in 1951 that accredits more than 20,000 US health care programs and organizations. [1] TJC's goal and mission are to ensure quality healthcare for patients, prevent harm, and improve patient advocacy.
To implement the Patient Safety Act, the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) published the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule). AHRQ has received many questions regarding the implementation of the Patient Safety Rule and about PSOs.
Often referred to as the Patient Safety Act, the provisions of this law dealing with PSOs are administered by the Agency for Healthcare Research and Quality (AHRQ) and the provisions dealing with its confidentiality protections are interpreted and enforced by the Office for Civil Rights (OCR).
Any information that is eligible to become PSWP reported to a PSO by a healthcare provider is protected. The definition of PSWP ( Patient Safety Rule Section 3.20) provides important detail on what information is eligible for protection and when those protections apply.
The PSO readmissions Web page contains helpful information and tools that can be used by such hospitals, and PSOs that work with those hospitals, to address the causes of unnecessary readmissions. In fact, any hospital can work with a PSO on any patient safety issue of the hospital's choice.
The uniform Federal protections that apply to a provider's relationship with a PSO are expected to remove significant barriers that can deter the participation of healthcare providers in patient safety and quality improvement initiatives , such as fear of legal liability or professional sanctions.
The Patient Safety Act and Rule provide protections that are designed to allay fears of providers of increased risk of liability if they voluntarily participate in the collection and analysis of patient safety events.
OCR is responsible for the investigation and enforcement of the confidentiality provisions of the Patient Safety Rule. OCR will investigate allegations of violations of confidentiality through a complaint-driven system.
The Patient Safety Act includes a provision at 42 U.S.C. § 299b-22(g)(6), the “FDA Rule of Construction,” which states that “[n ]othing in this section shall be construed . . . to limit, alter, or affect any requirement for reporting to the Food and Drug Administration information regarding the safety of a product or activity regulated by the Food and Drug Administration.” (emphasis added.) The Patient Safety Act added sections 921 to 926 to the Public Health Service Act. The “section” that is referenced in the FDA Rule of Construction is section 922 of the Public Health Service Act, 42 U.S.C. § 299b-22, which includes all of the Patient Safety Act’s privilege and confidentiality protections and exceptions. Thus, the privilege and confidentiality protections in the Patient Safety Act cannot be construed to limit, alter, or affect any requirement for reporting information to the FDA regarding the safety of an FDA-regulated product or activity.
The confidentiality requirements of the Patient Safety Act do not apply to or prohibit a “[d]isclosure by a provider to the Food and Drug Administration with respect to a product or activity regulated by the Food and Drug Administration .” 42 U.S.C. § 299b-22(c)(2)(D). The final rule implementing the Patient Safety Act regulation at 42 CFR 3.206(b)(7)(i) provides that the confidentiality provisions shall not apply to or prohibit: "Disclosure by a provider of patient safety work product concerning an FDA-regulated product or activity to the FDA, an entity required to report to the FDA concerning the quality, safety, or effectiveness of an FDA-regulated product or activity, or a contractor acting on behalf of FDA or such entity for these purposes.” Subsection (b)(7)(ii) provides that: “Any person permitted to receive patient safety work product pursuant to paragraph (b)(7)(i) of this section may only further disclose such patient safety work product for the purpose of evaluating the quality, safety, or effectiveness of that product or activity to another such person or the disclosing provider.”1
PSOs, and entities that seek to be PSOs, are reminded that an enti ty that is a unit or division of a legal entity, or that is owned, managed or controlled by one or more legally separate parent organizations, and that seeks to be a PSO, must apply as a component PSO. Thus, an entity that would be operating as a PSO and that is part of a larger organization that engages in FDA-regulated reporting activities, or that has a parent organization that engages in FDA-regulated reporting activities must seek listing as a component PSO. In addition, under 42 U.S.C. 299b-24(b)(1)(A), a PSO’s mission and primary activity must be to conduct activities to improve patient safety and the quality of health care delivery. Seeking listing as a component PSO helps to ensure that entities with multiple missions and activities (such as FDA-regulated reporting activities) are in compliance with this statutory requirement. Given the issues identified in this Guidance, AHRQ will also be engaging in additional inquiry of applicants and PSOs to determine whether the entity is organizationally related to an FDA-regulated reporting entity such that it should be listed as a component PSO (i.e., it is a unit or division of a legal entity, or is owned, managed or controlled by one or more legally separate parent organizations.) If the entity should be listed as a component PSO, AHRQ will work with the entity to pursue such appropriate listing.
The control and prevention of infectious diseases has been a primary mandate for government health authorities since the later part of the nineteenth century. In 1874, the State Board of Health of Massachusetts initiated a plan for the weekly voluntary reporting of prevalent diseases by physicians by postcard. In 1883, Michigan mandated the reporting of specific infectious diseases. By 1901, all states required notification of certain communicable diseases to state or local health authorities.
Some reasons for enacting such laws are: (a) gathering information for either epidemiological or statistical purposes; (b) protecting members of the public from harm from a communicable disease; (c) protecting members of the public from harm from a violent/criminal act (eg, reporting of gunshot wounds) or accidental injury by another party ; (d) protecting an individual patient from further harm caused by a perpetrator; or (e) assisting law enforcement in solving crimes or preventing future acts.
Failure to follow these laws could lead to civil liability, fines, or other penalties and problems on the part of the physician (eg, with a state medical board). 2. Permissive reporting laws allow, but do not compel, physicians to report certain conditions.
The emergency physician and others in the emergency department are uniquely positioned to identify people at risk or who pose a risk, and to report them as required or allowed under the law. In some circumstances, these duties may conflict with ethical duties such as respect for patient autonomy or to protect confidentiality. This article will examine mandatory and permissive reporting laws in various states from an ethical perspective. It will also explore emerging issues such as the reporting of suspected human trafficking.
1.4.1 Suspected child abuse. According to the Children's National Alliance, in 2015 there were 3.4 million referrals for suspected child abuse with ≈2/3 of these resulting in investigations by a child protective services agency. Approximately four out of five of the abusers were the children's parents.
(a) Every physician and surgeon shall report immediately to the local health officer in writing, the name, date of birth, and address of every patient at least 14 years of age or older whom the physician and surgeon has diagnosed as having a case of a disorder characterized by lapses of consciousness.
Had it been implemented, in the opinion of the authors, physicians would have been morally obligated to commit civil disobedience and not follow it, because following it likely would have deterred some patients from coming to the ED and resulted in harm to them for lack of health care.